Liner Ablation Using Contact-force in Atrial Fibrillation
NCT ID: NCT03091972
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-11-01
2018-12-31
Brief Summary
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The association between contact force values and successful linear block has not been revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
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Detailed Description
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Contact-force (CF) monitoring during procedure has recently been available. This technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (PV) isolation. It also helped to resolve the cause of PV reconnection. Some reports demonstrated that the association between reconnection and lower CF value.
Linear ablation has more variation to interrupt block and reconnection was more often than PV isolation. The association between CF values and successful linear block has not been revealed yet. In addition, the investigators aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Contact force assisted linear ablation
Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation
Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
Contact force assisted left atrial linear ablation
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.
control
Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
left atrial linear ablation without contact force monitoring
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
Interventions
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Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
Contact force assisted left atrial linear ablation
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.
left atrial linear ablation without contact force monitoring
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
Eligibility Criteria
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Inclusion Criteria
* Patients with persistent AF (AF episode lasting \> 7 days)
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
* Patients with recurrent or sustained arrhythmia after pulmonary vein isolation
* Patients undergoing a first-time ablation procedure for AF
* At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation
* Patients must be able and willing to provide written informed consent to participate in this investigation
Exclusion Criteria
* Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years.
* Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
* Patients with AF felt to be secondary to an obvious reversible cause
* Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
* Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view)
* Moderate to severe valvular disease
* Reduced left ventricular function (ejection fraction \<40%)
* Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.
18 Years
80 Years
ALL
Yes
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Korea University Anam Hospital
OTHER
Responsible Party
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Young-Hoon Kim
Professor
Locations
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Korea University Medical Center Anam hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Fassini G, Riva S, Chiodelli R, Trevisi N, Berti M, Carbucicchio C, Maccabelli G, Giraldi F, Bella PD. Left mitral isthmus ablation associated with PV Isolation: long-term results of a prospective randomized study. J Cardiovasc Electrophysiol. 2005 Nov;16(11):1150-6. doi: 10.1111/j.1540-8167.2005.50192.x.
Hocini M, Jais P, Sanders P, Takahashi Y, Rotter M, Rostock T, Hsu LF, Sacher F, Reuter S, Clementy J, Haissaguerre M. Techniques, evaluation, and consequences of linear block at the left atrial roof in paroxysmal atrial fibrillation: a prospective randomized study. Circulation. 2005 Dec 13;112(24):3688-96. doi: 10.1161/CIRCULATIONAHA.105.541052.
Willems S, Klemm H, Rostock T, Brandstrup B, Ventura R, Steven D, Risius T, Lutomsky B, Meinertz T. Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a prospective randomized comparison. Eur Heart J. 2006 Dec;27(23):2871-8. doi: 10.1093/eurheartj/ehl093. Epub 2006 Jun 16.
Gaita F, Caponi D, Scaglione M, Montefusco A, Corleto A, Di Monte F, Coin D, Di Donna P, Giustetto C. Long-term clinical results of 2 different ablation strategies in patients with paroxysmal and persistent atrial fibrillation. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):269-75. doi: 10.1161/CIRCEP.108.774885.
Santucci PA. Linear ablation of atrial fibrillation: what does it do? Heart Rhythm. 2010 Dec;7(12):1738-9. doi: 10.1016/j.hrthm.2010.09.001. Epub 2010 Sep 28. No abstract available.
Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.
Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
Andreu D, Gomez-Pulido F, Calvo M, Carlosena-Remirez A, Bisbal F, Borras R, Benito E, Guasch E, Prat-Gonzalez S, Perea RJ, Brugada J, Berruezo A, Mont L. Contact force threshold for permanent lesion formation in atrial fibrillation ablation: A cardiac magnetic resonance-based study to detect ablation gaps. Heart Rhythm. 2016 Jan;13(1):37-45. doi: 10.1016/j.hrthm.2015.08.010. Epub 2015 Aug 10.
le Polain de Waroux JB, Weerasooriya R, Anvardeen K, Barbraud C, Marchandise S, De Meester C, Goesaert C, Reis I, Scavee C. Low contact force and force-time integral predict early recovery and dormant conduction revealed by adenosine after pulmonary vein isolation. Europace. 2015 Jun;17(6):877-83. doi: 10.1093/europace/euu329. Epub 2015 Jan 24.
Other Identifiers
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LIBCAAF study
Identifier Type: -
Identifier Source: org_study_id
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